Amerge

DRUG DESCRIPTION

AMERGE Tablets contain naratriptan as the hydrochloride, which is a selective 5-hydroxytryptamine1 receptor subtype agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:

AMERGE® (naratriptan hydrochloride) Structural Formula Illustration

The empirical formula is C17H25N3O2S•HCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each AMERGE (naratriptan) Tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium; hypromellose; lactose; magnesium stearate; microcrystalline cellulose; triacetin; and titanium dioxide, iron oxide yellow (2.5-mg tablet only), and indigo carmine aluminum lake (FD&C Blue No. 2) (2.5-mg tablet only) for coloring.

What are the possible side effects of naratriptan (Amerge)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using naratriptan and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • ...

Read All Potential Side Effects and See Pictures of Amerge »

What are the precautions when taking naratriptan (Amerge)?

See also How to Use section.

Before taking naratriptan, tell your doctor or pharmacist if you are allergic to it; or to other triptan migraine drugs; or it you have other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be taken if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have a history of: heart disease (e.g., chest pain, heart attack), decreased blood flow in the brain (e.g., stroke, transient ischemic attack), blood circulation disease (e.g., ischemic bowel disease), uncontrolled high blood pressure (hypertension), certain types of headaches (hemiplegic or basilar migraine),...

Read All Potential Precautions of Amerge »


Amerge Consumer (continued)

SIDE EFFECTS: Flushing, sensations of tingling/numbness/prickling/heat, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Chest/jaw/neck tightness can commonly occur shortly after using naratriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell this apart from a serious reaction related to a lack of blood flow to the heart, brain or other parts of the body. Seek immediate medical attention if any of these unlikely but very serious (rarely fatal) side effects occur: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold sensation of hands/feet, hearing changes, mental/mood changes, seizures.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., sumatriptan, zolmitriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles.

In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also How to Use section.

Before taking naratriptan, tell your doctor or pharmacist if you are allergic to it; or to other triptan migraine drugs; or it you have other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be taken if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have a history of: heart disease (e.g., chest pain, heart attack), decreased blood flow in the brain (e.g., stroke, transient ischemic attack), blood circulation disease (e.g., ischemic bowel disease), uncontrolled high blood pressure (hypertension), certain types of headaches (hemiplegic or basilar migraine), kidney disease, liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood circulation disorders (e.g., Raynaud's disease), seizures.

Tell your doctor if you have the following risk factors for heart disease: diabetes, family history of heart disease, high blood pressure (controlled), high cholesterol, overweight, smoker, female after menopause, male over age 40.

If you are at high risk for heart disease, your doctor may want to check your heart before prescribing naratriptan.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

The risk of heart disease, liver disease, and high blood pressure increases with age. The manufacturer does not recommend the use of naratriptan in the elderly since they may be more sensitive to the side effects, especially to an increase in blood pressure.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Amerge Patient Information Including Side Effects

Brand Names: Amerge

Generic Name: naratriptan (Pronunciation: NAR a TRIP tan)

  • What is naratriptan (Amerge)?
  • What are the possible side effects of naratriptan (Amerge)?
  • What is the most important information I should know about naratriptan (Amerge)?
  • What should I discuss with my healthcare provider before using naratriptan (Amerge)?
  • How should I use naratriptan (Amerge)?
  • What happens if I miss a dose (Amerge)?
  • What happens if I overdose (Amerge)?
  • What should I avoid while using naratriptan (Amerge)?
  • What other drugs will affect naratriptan (Amerge)?
  • Where can I get more information?

What is naratriptan (Amerge)?

Naratriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain. Naratriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Naratriptan is used to treat migraine headaches.

Naratriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Naratriptan should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Naratriptan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of naratriptan (Amerge)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using naratriptan and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • sudden and severe stomach pain and bloody diarrhea;
  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
  • (if you are also taking an antidepressant) - agitation, high fever, sweating, fast or pounding heartbeats, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting.

Less serious side effects may include:

  • dry mouth, mild nausea;
  • feeling of pain or tightness in your jaw, neck, or throat;
  • pressure or heavy feeling in any part of your body;
  • dizziness, drowsiness, tired feeling; or
  • warmth, redness, or mild tingling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about naratriptan (Amerge)?

You should not take this medication if you are allergic to naratriptan, or if you have a history of heart disease, heart attack or stroke, angina (chest pain), blood circulation problems, ischemic bowel disease, severe liver or kidney disease, uncontrolled high blood pressure, or a headache that is not like other headaches you have had.

Do not use naratriptan within 24 hours before or after using another migraine headache medicine, including almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), rizatriptan (Maxalt), sumatriptan (Imitrex, Treximet), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Before taking naratriptan, tell your doctor if you have liver or kidney disease, high blood pressure, a heart rhythm disorder, coronary artery disease, or risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Before taking naratriptan, tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Naratriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

If your headache does not go away after taking a naratriptan tablet, or if the headache goes away and then comes back, call your doctor before taking a second tablet. You must wait at least four (4) hours after you have taken the first tablet before you take the second tablet. Do not take more than two (2) naratriptan tablets in 24 hours.

If your symptoms have not improved after taking 2 tablets in 24 hours, contact your doctor before taking any more tablets.

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